Professional Development:

• ​​Regulatory Affairs Medical Device Certification (RAC), RAPS, 2014
• Drug Development Process, UCSC Extension, 2013
  
• Leadership and Communication Executive Coaching, Simplified Coach, 2012-2013
  
• Microsoft Project 2010 Training, LearniT, 2013
  
• GMP, CFR, FDA Inspection Operational Training Course, Jeff Yuen & Associates, 2011
  
• Project Management Training, AMA, 2008
  
• Management Essentials Training, Roadmap to Leadership, 2008

Knowledge Profile:

Mrs. Stewart has over 20 years of experience as a product development professional, who possesses vast experience working with cross-functional teams with a strong focus on Product Development, Program Management, and Quality Assurance within the FDA-regulated Life Science and Medical Device Industries. Success begins with building productive relationships between vendors, CMO's, R&D, Quality, Engineering, Analytical, Regulatory, and other corporate teams to meet critical deadlines and performance targets. 

Extensive Knowledge in:

• Pharmaceuticals and Medical Device Product Development Project Management
• Design Control Project Management
• Cross-functional CMC Project Management
• Technical Batch Review and Release of Product
• Change Control, Deviation, and CAPA Management
• IND & NDA Authoring CMC Sections
• CMO Management